NIACIN - Generic Drug Details

What are the generic sources for niacin and what is the scope of freedom to operate?

Niacin is the generic ingredient in seven branded drugs marketed by Medpointe Pharm Hlc, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Abbvie, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Avondale Pharms, Sanofi Aventis Us, and Intl Minerals, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for niacin. Eleven suppliers are listed for this compound.

Summary for NIACIN

US Patents:	0
Tradenames:	7
Applicants:	28
NDAs:	35
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	211
Clinical Trials:	171
Patent Applications:	7,064
Drug Prices:	Drug price trends for NIACIN
Drug Sales Revenues:	Drug sales revenues for NIACIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NIACIN
What excipients (inactive ingredients) are in NIACIN?	NIACIN excipients list
DailyMed Link:	NIACIN at DailyMed

See drug prices for NIACIN

See drug sales revenues for NIACIN

Recent Clinical Trials for NIACIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval	N/A
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	N/A
Rhode Island Hospital	Early Phase 1

See all NIACIN clinical trials

Pharmacology for NIACIN

Drug Class

Nicotinic Acid

Medical Subject Heading (MeSH) Categories for NIACIN

Hypolipidemic Agents

Vasodilator Agents

Vitamin B Complex

US Patents and Regulatory Information for NIACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	090892-001	Mar 20, 2014	AB	RX	No	No
Chartwell Rx	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	090860-001	Mar 20, 2014	AB	RX	No	No
Amneal Pharms	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	204178-001	Dec 11, 2015	AB	RX	No	No
Jubilant Generics	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	209156-002	May 14, 2018		DISCN	No	No

Expired US Patents for NIACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997	7,998,506
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-001	Jul 28, 1997	6,080,428
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997	6,129,930
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-003	Jul 28, 1997	7,998,506

NIACIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Niacin and Niacinamide

Global Market Overview

The global niacin and niacinamide market is experiencing significant growth, driven by several key factors. As of 2021, the market was valued at approximately USD 1.2 billion and is projected to reach USD 2.5 billion by 2032, growing at a robust Compound Annual Growth Rate (CAGR) of 5.2% from 2022 to 2032[1][3].

Drivers of Market Growth

Increasing Focus on Health and Wellness

The rising awareness of health and wellness globally is a major driver for the niacin and niacinamide market. Consumers are increasingly seeking supplements and products that address various health concerns, including cardiovascular health, skincare, and nutritional deficiencies[3].

Benefits of Niacin and Niacinamide

Niacin and niacinamide offer a range of health benefits, including maintaining vitamin B3 levels, reducing cholesterol, and enhancing energy metabolism. These benefits are crucial in preventing and treating conditions such as hyperlipidemia, dyslipidemia, and hypertriglyceridemia[2][5].

Rising Healthcare Expenditure

Global healthcare expenditure is on the rise, with governments and private institutions allocating more funds to preventive and therapeutic measures. This increase in healthcare spending is driving the demand for medications and nutritional supplements, including niacin and niacinamide[3].

Geographical Market Dynamics

North America

North America is a dominant market for niacin, driven by increasing obesity and critical health issues among the population. The region is expected to witness steady growth due to the strong focus on health and wellness[3][4].

Asia Pacific

The Asia Pacific region, particularly countries like India and China, is emerging as a significant market. India accounted for a 15.3% market share in 2021 and is expected to see lucrative growth due to the rapid development of the healthcare sector and rising disposable incomes[1].

Europe

Europe, with its robust pharmaceutical industry and growing demand for functional foods, is anticipated to contribute significantly to market expansion. The region's focus on health and wellness, along with advancements in medical research, is driving the demand for niacin and niacinamide[3].

Latin America and Middle East & Africa

These regions are also poised for considerable growth, driven by evolving pharmaceutical and personal care industries, improving healthcare infrastructure, and growing consumer awareness[3].

Segmentation by Application

Health Supplements

The use of niacin and niacinamide in health supplements is a key driver of market growth. These ingredients are essential for maintaining vitamin B3 levels and addressing various health concerns, including cardiovascular health and nutritional deficiencies[1][4].

Pharmaceutical Sector

Niacin is used in the pharmaceutical sector to treat conditions such as hyperlipidemia, dyslipidemia, and hypertriglyceridemia. Its use in combination with other medications, like simvastatin or lovastatin, further boosts its demand[2].

Cosmetic and Personal Care Industry

The increasing use of liquid niacinamide in skincare products is a significant factor driving market growth. Niacinamide is preferred by dermatologists and aestheticians for its ability to brighten the skin, reduce acne, and hydrate the skin[1][3].

Distribution Channels

The pharmacies & drug stores segment dominated the market in 2021, with a share of around 64.5%. This channel is the most widely adopted for self-prescribed drugs and daily use products in skin rejuvenation and other applications[1].

Key Players and Market Strategies

Key players in the niacin and niacinamide market are focusing on introducing disruptive solutions, obtaining regulatory approvals, establishing new labs, and engaging in mergers and acquisitions. These strategies aim to expand product offerings and capitalize on emerging opportunities[1].

Financial Projections

• Market Size: The global niacin and niacinamide market was valued at USD 1.2 billion in 2021 and is expected to reach USD 2.5 billion by 2032[1].
• CAGR: The market is projected to grow at a CAGR of 5.2% from 2022 to 2032[1][3].
• Regional Growth: India, China, the USA, Japan, and Germany are among the top countries driving the demand for niacin and niacinamide[1].

Illustrative Statistics

• Market Share: India accounted for a 15.3% market share in 2021, while China led the East Asia market with a share of around 7.5%[1].
• Health Benefits: Niacin can increase HDL cholesterol levels by 10%–30% and reduce LDL cholesterol levels by 10%–25%, triglyceride levels by 20%–50%, and lipoprotein(a) levels by 10%–30%[5].

Expert Insights

"Niacinamide is the most essential ingredient in the skincare regime. Liquid niacinamide aids in brightening the skin, reducing acne or flaws on the skin, and also hydrates. Hence, numerous dermatologists and aestheticians prefer niacinamide as the most essential ingredient in beauty treatments."[1]

Key Takeaways

• The global niacin and niacinamide market is growing at a CAGR of 5.2% from 2022 to 2032.
• Increasing awareness of skincare and health benefits are key drivers of market growth.
• The Asia Pacific region, particularly India and China, is expected to see significant growth.
• The use of niacin and niacinamide in health supplements, pharmaceuticals, and cosmetics is driving market expansion.
• Key players are focusing on innovative solutions and strategic expansions to capitalize on emerging opportunities.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of the global niacin and niacinamide market by 2032? A: The global niacin and niacinamide market is expected to reach USD 2.5 billion by 2032[1].

Q: What is the primary driver of the niacin and niacinamide market growth? A: The primary drivers include increasing awareness of skincare, health benefits, and rising healthcare expenditure[1][3].

Q: Which regions are expected to see significant growth in the niacin and niacinamide market? A: The Asia Pacific region, particularly India and China, along with North America and Europe, are expected to see significant growth[1][3].

Q: What are the key applications of niacin and niacinamide? A: Key applications include health supplements, pharmaceuticals, and the cosmetic and personal care industry[1][2].

Q: What is the role of niacin in treating cardiovascular diseases? A: Niacin is used to treat high blood cholesterol levels and can increase HDL cholesterol levels while reducing LDL cholesterol and triglyceride levels[2][5].

Cited Sources:

1. Future Market Insights: Niacin and Niacinamide Market Size, Share, Outlook & Trend - 2032
2. DrugBank Online: Niacin: Uses, Interactions, Mechanism of Action
3. ReAnIn: Niacin and Niacinamide Market | Growth | Share | Size
4. Persistence Market Research: Niacin Market: Global Industry Trend Analysis 2013 to 2017 and ...
5. National Institutes of Health: Niacin - Health Professional Fact Sheet